BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS V60

    MDR report key: 3121675 · Received April 4, 2013

    Report

    Report Number
    3121675
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    February 13, 2013
    Report Date
    April 4, 2013
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE MACHINE BEGAN ALARMING. THE RESPIRATORY THERAPIST THAT WAS PRESENT SAID THE MACHINE SHOWED A "WATCHDOG ERROR". THE PATIENT HAD DIFFICULTY BREATHING AND HER OXYGEN SATURATION DROPPED. THE THERAPIST THEN SWITCHED THE PATIENT TO A NON-REBREATHE MASK AND EXCHANGED THE BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP) MACHINE. NO PATIENT HARM. THE MACHINE WAS CHECKED BY THE HOSPITAL BIO-MED DEPARTMENT AND ONE OR MORE LOOSE CONNECTIONS WITHIN THE UNIT WERE FOUND AND REPAIRED. COMPLETE PREVENTATIVE MAINTENANCE WAS DONE AFTER THE REPAIR AND THE MACHINE WAS RETURNED TO SERVICE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?RESPIRATORY THERAPY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139693 RESPIRONICS V60 VENTILATOR CBK PHILIPS HEALTHCARE V60 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *